Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration

Conditions

• Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ixo-vec — GENETIC
  Ixo-vec (6 × 10\^10 vg/eye) will be administered intravitreally

Study Details

The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and/or participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye. Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy. The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.

Key Dates

Start date

Jun 2, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2031

Completion

Jun 30, 2031

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ixo-vec dosing in Contralateral Eye
  Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants.

Primary Outcome Measure

Incidence of ocular adverse events (AEs) [ Time Frame: Baseline through Week 28 ]

Central Contacts

• Adverum Study Contact
  650-656-9323
  [email protected]

Locations (4)

Find similar trials in Deerfield Beach, FL